The evaluation of Tenecteplase for the treatment of ischemic stroke (real-world data)

The study reinforces the use of Tenecteplase (TNK) dosed at 0.25 mg/kg in real-world community settings as an effective and safe alternative to alteplase standard dosing.

The aim of this study is to evaluate the effectiveness and safety of TNK compared to alteplase in a community healthcare setting for treating ischemic stroke, including patients with large vessel occlusion (LVO) who were candidates for mechanical thrombectomy, as well as those with non-large-vessel ischemic stroke.

This was a multicenter, retrospective cohort study across 11 primary and comprehensive hospitals within the BayCare Health System in West Central Florida (December 2019-April 2024), comparing TNK 0.25 mg/kg (max 25 mg) with standard-dose alteplase among adults with acute ischemic stroke presenting within 4.5 h of last-known-well. A total of 476 patients were evaluated retrospectively, with 270 patients in the Alteplase arm and 206 patients in the TNK arm.

The primary outcome (LVO subgroup) was substantial early reperfusion prior to thrombectomy, defined as restoration of blood flow to >50% of the ischemic territory (mTICI 2b/2c/3) by CTA/MRA or absence of a retrievable thrombus at the initial angiographic assessment. A LVO was determined at the initial CT/CTA prior to the thrombectomy. Secondary outcomes included door-to-needle time (DTN), NIHSS at 24 h, discharge NIHSS, discharge disposition, 90-day mRS, and safety (symptomatic/asymptomatic ICH by system definitions and angioedema). Safety outcomes for ICH were assessed using the SITS-MOST criteria for symptomatic ICH including subarachnoid hemorrhage within 24 h of treatment combined with an increase from baseline in NIHSS score of at least 4 points.

Of the 476 AIS patients (TNK n = 270; alteplase n = 206), 226 had LVO (TNK n = 115; alteplase n = 111). Early reperfusion occurred in 14.8% treated with TNK vs. 4.5% with alteplase (risk difference 10.3% [95% CI, 2.7-17.8], p = 0.008). Adjusted odds of early reperfusion were higher with TNK (OR 3.53 [95% CI, 1.20-10.40], p = 0.022). In all AIS patients, median DTN time was shorter with TNK (34 vs. 45 min; difference -11 [95% CI, -14.4 to -7.6], p < 0.001). Good 90-day functional outcome (mRS 0-2) was more common with TNK among LVO patients (47.3% vs. 29.3%, p = 0.031) and among all AIS patients (61.8% vs. 50.0%, difference 11.8% [95% CI, -0.3 to 23.4], p = 0.044). Symptomatic ICH and angioedema were similar; across all patients combined, ICH (symptomatic and asymptomatic) was less frequent with TNK (8.5% vs. 15.0%, p = 0.030).

In a community-hospital system, TNK 0.25 mg/kg IV was associated with higher pre-thrombectomy reperfusion in LVO, shorter door-to-needle times, comparable safety, and improved functional outcomes versus alteplase in key analyses. These findings align with recent randomized evidence and support TNK 0.25 mg/kg as an effective alternative to alteplase for AIS.